Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT04474951
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C048862', 'term': 'stinging nettle lectin'}, {'id': 'C015424', 'term': 'peppermint oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anemia', 'timeFrame': 'Patients will be followed from date of enrollment for a maximum period of 6 months. Hemoglobin levels monitoring performed for a maximum period of 6 months or until the worsening of anemia (Hb<10 g/dL).', 'description': 'Assessment of hemoglobin levels every 4 weeks.'}, {'measure': 'Fatigue', 'timeFrame': 'Patients will be followed from date of enrollment for a maximum period of 6 months.', 'description': 'Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.'}, {'measure': 'Nausea', 'timeFrame': 'Patients will be followed from date of enrollment for a maximum period of 6 months.', 'description': 'Evaluation of nausea with questionnaire "Multinational Association of Supportive Care in Cancer" - MAT, completed by the patients at day 2 and day 5 of every cycle of chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Quality of life level: questionnaire', 'timeFrame': 'Patients will be followed from date of enrollment for a maximum period of 6 months.', 'description': 'Evaluation of quality of life with questionnaire EQ-5D, completed at day 1 of every cycle of chemotherapy by patients enrolled in the three arms.'}, {'measure': 'Tolerability of food supplements', 'timeFrame': 'Patients will be followed from date of enrollment for a maximum period of 6 months.', 'description': 'Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'ovarian cancer', 'stinging nettle', 'peppermint', 'anemia', 'fatigue', 'nausea'], 'conditions': ['Breast Cancer', 'Gynecologic Cancer']}, 'referencesModule': {'references': [{'pmid': '23390455', 'type': 'BACKGROUND', 'citation': 'Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha x piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31.'}, {'pmid': '26904610', 'type': 'BACKGROUND', 'citation': 'Rutto LK, Xu Y, Ramirez E, Brandt M. Mineral Properties and Dietary Value of Raw and Processed Stinging Nettle (Urtica dioica L.). Int J Food Sci. 2013;2013:857120. doi: 10.1155/2013/857120. Epub 2013 May 16.'}, {'pmid': '14716106', 'type': 'BACKGROUND', 'citation': 'Meral I, Kanter M. Effects of Nigella sativa L. and Urtica dioica L. on selected mineral status and hematological values in CCl4-treated rats. Biol Trace Elem Res. 2003 Winter;96(1-3):263-70. doi: 10.1385/BTER:96:1-3:263.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the impact of food supplements (herbal remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea. Secondary aims of the trial are to evaluate the impact of these supplements on the quality of life and to evaluate their tolerability profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female ≥ 18 years\n* Karnofsky Performance Scale (KPS) ≥ 90%\n* Breast or Gynecological cancer\n* Informed consent signed before every procedure study specific, on day 1 of therapy cycle\n* Inclusion Criteria Arm 1: presence of grade 1 anemia as per CTCAE 4.0 criteria; patients on treatment with anti-CDK 4/6 or PARP Inhibitors or in adjuvant therapy with hormone therapy\n* Inclusion Criteria Arm 2: presence of fatigue of any grade; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane\n* Inclusion Criteria Arm 3: presence of nausea of any grade, without vomiting; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane\n\nExclusion Criteria:\n\n* Arm 1, 2 and 3: Previous intake of food supplements within 4 weeks from the enrollment\n* Arm 2: patients with evidence of anxiety or anxious-depressive syndrome; Clinical hypothyroidism not compensated by replacement therapy; Persistent insomnia\n* Arm 3: patients with evidence of anxiety or anxious-depressive syndrome'}, 'identificationModule': {'nctId': 'NCT04474951', 'acronym': 'GALENO 1', 'briefTitle': 'Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies', 'orgStudyIdInfo': {'id': 'GALENO 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anemia', 'description': 'Metastatic patients with grade 1 anemia and on treatment with anti-CDK 4/6 or PARP Inhibitors (10 patients) or on adjuvant therapy with hormonal therapy (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; hemoglobin levels will be assessed every 4 weeks for a maximum period of 6 months.', 'interventionNames': ['Dietary Supplement: Stinging Nettle']}, {'type': 'EXPERIMENTAL', 'label': 'Fatigue', 'description': 'Patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing fatigue not associated to anemia or with anemia grade 1 (10 patients) or associated to anemia grade 2 (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; the assessment of fatigue will be performed at every chemotherapy cycle, for a maximum period of 6 months.', 'interventionNames': ['Dietary Supplement: Stinging Nettle']}, {'type': 'EXPERIMENTAL', 'label': 'Nausea', 'description': '20 patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing nausea of any grade (without vomiting) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Peppermint Fluid Extract, associated to antiemetic therapy prescribed as per clinical practice; the assessment of nausea will be performed at every chemotherapy cycle, for a maximum period of 6 months.', 'interventionNames': ['Dietary Supplement: Peppermint']}], 'interventions': [{'name': 'Stinging Nettle', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.', 'armGroupLabels': ['Anemia']}, {'name': 'Stinging Nettle', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.', 'armGroupLabels': ['Fatigue']}, {'name': 'Peppermint', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.', 'armGroupLabels': ['Nausea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio Zamagni, MD', 'role': 'CONTACT', 'email': 'zamagniclaudio.sper@aosp.bo.it', 'phone': '051 2144548', 'phoneExt': '+39'}], 'facility': 'Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Claudio Zamagni, MD', 'role': 'CONTACT', 'email': 'zamagniclaudio.sper@aosp.bo.it', 'phone': '051 2144548', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Claudio Zamagni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Medical Oncologist', 'investigatorFullName': 'Claudio Zamagni MD', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}